RegWardenFDA facility compliance records
Company

Agilent Technologies, Inc

5 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2015: 1 recalls; 2018: 1 recalls; 2022: 1 recalls; 2024: 1 recalls; 2025: 1 recalls12015201620171201820192020202112022202312024120252026
  • Recalls (5)

Registered facilities (9)

Recalls & enforcement

  • Class IIOngoing2025-03-20
    DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, res…
  • Class IIOngoing2024-04-02
    There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
  • Class IIIOngoing2022-05-20
    Label provided for substrate vail contained incorrect expiration date.
  • Class IITerminated2018-08-15
    When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch between the sample name and the column header whereby the sample header will be offset by o…
  • Class IITerminated2015-06-17
    The product was marketed without 510(k) clearance.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Agilent Technologies, Inc — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10038794-agilent-technologies-inc/

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